MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 48OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121882748

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the cermamic pinnacle insert was broken.

Event Description

Additional information received.A.Did it break into two or more pieces? if no, please specify the alleged deficiency of the instruments.Were they bent, stripped, cross threaded, etc.? yes.B.Can you please provide the reason why the cup was revised? was there any alleged deficiency? the cup is revised because it was not possible to extract the ceramic liner.C.Was there a surgery delay? if yes, what was the duration of the delay? yes 15 min.D.Was the patient experiencing any adverse symptoms/consequence that led to the revision surgery? no.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, h6 health effect - impact code & medical device problem code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary = according to the information received, ¿broken cermamic pinnacle insert¿.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device along with supplier investigation performed by supplier.Further details of the device's analysis were attached on "231004 final report kiv 23 08 03.Pdf".Visual analysis of the returned sample revealed that delta cer insert 32id x 48od has fractured into multiple pieces.One large fragment of the ceramic insert was found fixated in the acetabular cup and seven more fragments were returned for evaluation.However, the ceramic insert cannot be completely reconstructed from the delivered fragments.Metal transfer of erratic appearance can be observed on the outer surface of the fracture fragments, most likely caused by caused by chafing between metal parts and/ or surgical instruments.Additionally, the rim of the large fragment was found chipped over almost the whole circumference and presents signs of metal transfer.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed damage of the delta cer insert 32id x 48od may have been caused by a misalignment during the process of positioning the insert.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.The overall complaint was confirmed as the observed condition of the delta cer insert 32id x 48od would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = the ceramic insert belongs to the shop order 7011722360.Protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.The component properties and the microstructure as obtained from the quality documents of the insert meet the requirements specified at the time of production.There is no indication of any pre-existing material defect.Device history review = a manufacturing record evaluation was performed for the finished device [121882748 / 3999667] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Added: g4 (510k).

• Brand Name: DELTA CER INSERT 32ID X 48OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17152346
• MDR Text Key: 317460590
• Report Number: 1818910-2023-12422
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121882748
• Device Lot Number: 3999667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 06/30/2023; 08/01/2023; 10/24/2023
• Supplement Dates FDA Received: 07/07/2023; 08/02/2023; 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PINN 100 W/GRIPTION 48MM
• Patient Outcome(s): Required Intervention